Surfactant Replacement Guided by Early Lung Ultrasound Score in Preterm Newborns With Respiratory Distress Syndrome

Preterm Birth Clinical Trial

— ECHOSURF  

Official title:

Surfactant Replacement Guided by Early Lung Ultrasound Score (LUS) in Preterm Newborns < 33 Weeks With Respiratory Distress Syndrome in the Neonatal Intensive Care Unit of Saint-Etienne.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04775459
• Other study ID #: IRBN232021/CHUSTE
• Status: Not yet recruiting
• Start date: March 1, 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: February 2021
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Aurelie CANTAIS, MD
• Phone: (0)477829295
• Email: aurelie.cantais[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Lung immaturity is a major issue in neonatal unit.The surfactant administration improves the pulmonary prognosis in premature infants with hyaline membrane disease who escape continuous positive airway pressure (CPAP). This surfactant had been administered at 5h25min of life in Saint Etienne from 2016 to 2019. Studies suggest that the earlier the surfactant is administered, the more it can reduce the rate of bronchodysplasia and mortality. And some studies show a pulmonary ultrasound could help to administrate the surfactant earlier This is why a new faster strategy for diagnosing preterms needing surfactant will be usefulness and have been done in Saint-Etienne since 2021 thanks to a ultrasound score (LUS).

Description:

This current study analyzes the impact of early Lungs Ultrasounds which use a semi-quantitative assessment : the Lung Ultrasound Score (LUS), in preterms <33 weeks on the time to surfactant administration. The current hypothesis is that Lung Ultrasound can increase the number of preterms with surfactant replacement within the first 3 hours of life. This is a prospective, comparative, observational trial between two different cohorts : the last 6 months of 2019 (without Score LUS) versus the first 6 months of 2021 (with Score LUS).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Day

Eligibility

Inclusion Criteria:

• newborns <33 weeks old
• born at the Saint Etienne University Hospital
• respiratory distress syndrome

Exclusion Criteria:

• chromosomal abnormality,
• multi-polymalformations syndrome,
• congenital pulmonary disease,
• septic shock,
• congenital lung infection,
• meconium inhalation,
• pneumothorax
• conditions requiring surgery in the first week of life.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• Surfactant administration until 2020
Surfactant is administrated if Fi02 >30% among the Guidelines of 2019
• Surfactant administration since 2021
Surfactant is administrated if Fi02 >30% OR if score LUS >8/18 among the literature

Locations

Country	Name	City	State
France	Chu de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	administration time frame (min of life)	Time from birth to surfactant administration	day 1
Secondary	FiO2 maximum	Collect in medical record.: the maximal value of FiO2 from birth to one week of life	Week 1
Secondary	delay from FiO2 maximum to FiO2 < 21%	Collect in medical record	Week 4
Secondary	Ventilation time (day)	Collect in medical record : number of day using a ventilation	Week 4
Secondary	Ventilation support	Collect in medical record : using a invasive ou a non invasive ventilation	Week 4
Secondary	Bronchodysplasia rate	Collect in medical record.	Week 4